Monoclonal Antibodies - Comments received on the Guidelines

In middle of December, the European Medicines Agency (EMEA) published an overview of comments received on the guideline "Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products". Eleven Companies and Organisations files in their comments on that draft guideline to EMEA.

The most of them welcomed the guideline generally, but they have significant concerns related to the alignment of the proposed guidance with existing guidelines like ICH or regional guidelines.

Some of the announced concerns are related to:

  • Limitation of the risk based approach to process control and product quality, what's contrary to the principles of ICH Q8, Q9 and Q10
  • Not enough information from the section of glycosylation
  • No clear definition and possible misunderstanding of terms like "related substances"

In June 2008, the Biologics Working Party Drafting Group and scientific experts from European trade associations discussed the comments during a meeting at EMEA. The outcome of this meeting is reflected in this document too.

To find the detailed information about the comments and the outcome of the meeting in 2008 please go here.

The ECA Conference “Development of Biopharmaceuticals – Preclinical and Clinical Phases” in Prague, Czech Republic, on 30 March to 1 April 2009 will provide you with an insight in all relevant aspects of preclinical and clinical development, method development and qualification as well as regulatory requirements.

Axel Schroeder
On behalf of the European Compliance Academy (ECA)

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